Cape Cod Hospital recently agreed to pay $24.3 million to resolve False Claims Act allegations that the hospital knowingly submitted claims to Medicare for transcatheter aortic valve replacement (TAVR) procedures that were not compliant with Medicare rules that specify the way in which hospitals are required to evaluate patient suitability for the procedures.
The claim was originally brought under the qui tam provisions of the False Claims Act by a former physician employed by Cape Cod Hospital. The individual who brought forth the claim will receive more than $4 million as their share of the settlement.
According to the settlement, Cape Cod Hospital began to offer TAVR procedures for patients suffering from aortic stenosis in 2015. Under Medicare rules at the time, prior to performing a TAVR procedure, hospitals were required to engage specific clinical personnel to perform an independent examination of prospective patients to evaluate their suitability for TAVR, document the rationale for their clinical judgment, and make the rationale available to the medical team performing the TAVR procedure. On June 21, 2019, the rules changed to require an interventional cardiologist and one cardiac surgeon perform the independent examination, but the documentation requirement did not change.
Under the settlement, Cape Cod Hospital allegedly knowingly submitted hundreds of claims to Medicare for TAVR procedures that did not comply with the requirements from November 1, 2015, through December 31, 2022 . In some cases, not enough clinicians reviewed a patient’s suitability for the procedure, while in other instances, the physicians did not document and share their clinical judgment rationale with the medical team performing the TAVR procedure.
Cape Cod Hospital agreed to pay $24,393,507, plus interest of 4.375% per annum. Of the settlement amount, $14,075,982.91 is restitution.
Under the terms of the settlement, Cape Cod Hospital did receive credit for taking disclosure, cooperation, and remediation into account in False Claims Act cases. Cape Cod Hospital did voluntarily produce materials, identify relevant medical records, and admit that it failed to adhere to the relevant Medicare requirements. The hospital also implemented appropriate remedial measures.
Corporate Integrity Agreement
Cape Cod Hospital also entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS OIG). The CIA requires, among other things, an annual review of its paid Medicare claims by an Independent Review Organization.
DOJ Statement
“Medicare permitted coverage for this newly developed cardiac procedure only under certain conditions to ensure patient safety. Cape Cod Hospital ignored those rules and received millions of dollars from Medicare to which it was not entitled. This conduct persisted for years despite internal warnings,” said Acting U.S. Attorney Joshua S. Levy for the District of Massachusetts. “This investigation and settlement ensures that patient safety is prioritized over a hospital’s bottom line.”